Non-weight Bearing Exercise for Accelerated Healing of Diabetic Foot Ulcers

NCT05603273 | Recruiting DMC

• 2 other identifiers: HUM00202034DISP
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to improve the therapeutic management of diabetic foot ulcers (DFU). The main questions to answer are if a program of non-weight bearing exercise helps the DFU heal faster than standard wound care. This randomized clinical trial will determine how blood flow to the ulcer and whole body metabolism may be improved with exercise. Participants will be randomized to either exercise + standard wound care or standard wound care alone and undergo testing for leg blood flow, fitness and measures of metabolism through blood draws. The intervention period is 6-weeks. Eligible participants must have an existing foot ulcer uncomplicated by infection and be medically cleared to exercise.

Conditions

Type2diabetes; Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• wound size and depth

  wound site and depth

  6 weeks

Secondary Outcomes (1)

• blood flow

  6 weeks

Study Arms (2)

standard wound care

NO INTERVENTION

normal wound care according to current clinical practice

non-weight bearing exercise + standard wound care

EXPERIMENTAL

normal wound care according to current clinical practice with the addition of a weekly exercise routine

Behavioral: non-weight bearing exercise

Interventions

non-weight bearing exercise BEHAVIORAL

exercise on a non-weight bearing device at 50% of peak capacity, 3 days per week for 6 weeks

non-weight bearing exercise + standard wound care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or Female, aged 18 yrs or older
• Diabetes diagnosed or meets ADA criteria for Type 2 diabetes
• Foot ulcer of diabetic etiology, with all of the following characteristics:
• Ulcer size \> 0.5cm2 and \< 12cm2 at least 2 cm from any other ulcer
• Ulcer with Wagner grade 1 or 2

You may not qualify if:

• Patient participating in an interventional clinical trial within 1 month of visit 1
• Participant has Charcot's foot or other foot deformities that prevent adequate targeted ulcer offloading
• Participant has active severe infection or osteomyelitis at the time of the screening visit
• History of cancer within the last 3 years, other than non-melanoma skin cancer
• Use of adjunctive therapy within previous 30 days
• Currently receiving medication considered to be a systemic glucocorticoid
• Plan to perform a vascular intervention, such as surgical bypass, angioplasty or stenting, or \< 1 month from a prior ipsilateral (same side) vascular intervention
• Pregnant or currently lactating
• Uncontrolled blood glucose with presence of urinary ketones
• Contraindications for exercise as define by the American Heart Association/American College of Sports Medicine Guidelines for Exercise Testing and Prescription \[1\]
• Bilateral wound or ulcer
• Current infection of COVID19
• Any history of concomitant medical condition that, in the opinion of the investigator(s), would compromise the participants ability to safely complete the study

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

School of Kinesiology

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Foot Ulcer

Condition Hierarchy (Ancestors)

Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Leg Ulcer; Skin Ulcer

Study Officials

• Jacob Haus, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacob Haus, PhD

CONTACT

734 647 2790; jmhaus@umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized control trial

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: November 2, 2022
• Study Start: December 13, 2023
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)